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Review of the Fialuridine (FIAU) Clinical Trials (1995) / Chapter Skim
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Summary of Patient Interviews
Pages 90-92

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From page 90...
... Eight of these 14 participated only in the R91 trial, four were subjects in both the R91 and PPPC trials, and 2 participated only in the PPPC trial. Although the numbers of patients from each study are far too small to allow any meaningful quantitative analysis, the committee felt that some firsthand information from the patients themselves was necessary to properly evaluate both the possibly self-serving accounts of the scientists and drug companies on the one hand and the often sensational media accounts charging or implying systematic negligence, indifference, or even willful misrepresentation on the other hand.
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From page 91...
... interviewed reported that they would not consider volunteering for further drug trials with their previous investigators under any circumstances. An important commonality among the six patients in the PPPC trial was their universal recall of discussion during the informed consent process about the death of one of the patients in the PPPC trial 4 months after completing FIAU therapy, following surgical removal of his gallbladder.
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From page 92...
... The doctor-patient relationship finally ruptured with the patient's very strongly worded testimony to this effect to the FDA Antiviral Advisory Committee in September of 1993 and a subsequent letter to him from Hoofnagle informing him that in view of those remarks he did not think it appropriate for NIH to continue providing medical care or advice. Upon appeal to the Acting Director of NIH the patient was extended a formal apology, assured that he would receive the same opportunities for assistance as other former trial participants, and given a new point of contact at NIH, the Clinical Director of NIDDK.
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Key Terms

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  • subjects interviewed
  • peripheral neuropathy
  • consent process
  • informed consent

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  • nih study
  • nih patients
  • pppa trial
  • drug companies

  • five subjects
  • interviewed reported
  • initial contact
  • interviewed recalled
  • sensational media

  • subsequent letter
  • reported currently
  • investigators sometime
  • legal action
  • providing medical

  • currently suffering
  • trial died
  • fiau therapy
  • committee reviewing
  • icd actually

  • subjects enrolled
  • fiau treatment
  • completing fiau
  • excellent rapport
  • patient representative


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